Controlled Study of the Use of Quetiapine Fumarate in the Treatment of Patients With Bipolar Depression

A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00083954

Enrollment

530

Registered

2004-06-07

Start date

2004-06-30

Completion date

2005-08-31

Last updated

2013-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Bipolar I Disorder

Brief summary

The purpose of this study is to determine the efficacy of quetiapine compared to placebo in the treatment for a major depressive episode in patients with bipolar disorder after receiving treatment for up to 8 weeks.

Interventions

DRUGQuetiapine Fumarate

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Provision of informed consent before enrollment and any study-specific procedures. Patients deemed incapable of providing written consent will not be enrolled in this study; outpatient status

Exclusion criteria

* More than 8 mood episodes in the past year from screen (visit 1); * A current Axis I disorder other than bipolar disorder within 6 months of screening; * patients with clinically significant abnormal laboratory findings in the investigator's judgment

Design outcomes

Primary

Measure	Time frame
Change from baseline to week 8 in the Montgomery-Asberg Depression Rating Scale (MADRS) total score	—

Secondary

Measure	Time frame
Evaluate the incidence of treatment-emergent mania compared to placebo	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026